Unexplained Infertility - Information For Physicians

Information for Healthcare Professionals

ReceptivaDx^TM is a new and improved test for endometrial receptivity. It provides enhanced screening for all stages of endometriosis and other conditions that interfere with implantation.

This is the first test for endometriosis with high sensitivity and specificity (96%). It is especially useful for women with unexplained IVF failure or infertility. While other tests evaluate the quality of embryos or determine optimal embryo transfer windows, only ReceptivaDx can accurately detect inflammatory conditions on the uterine lining. The results can help indicate what is likely causing implantation issues.

The test specifically identifies BCL6, a protein biomarker associated with inflammation. BCL6 is dramatically over-expressed in women with endometriosis, which makes it a likely candidate for the cause of progesterone resistance that contributes to implantation problems (read blog post).

Progesterone is required for a normal pregnancy, so a protein that interferes with progesterone action would explain much about the problems encountered in women with endometriosis.

Studies have shown that women with elevated BCL6 results are 5 times less likely to succeed in IVF or subsequent transfer attempts. A negative BCL6 result provides reassurance to patients that endometriosis is not of concern. A recent cohort study in the December 2017 issue of Fertility and Sterility demonstrated the prognostic value of BCL6 results. Results were successful in predicting the likelihood of live birth on the next IVF transfer for patients experiencing unexplained infertility prior to the transfer.

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Frequently Asked Questions

If a Patient Tests Positive for BCL6, What Are the Protocols for Treatment?

IVF centers typically treat positive BCL6 patients with 60-90 days of GnRH agonists like Depot Lupron(R), followed by an embryo transfer 5 to 6 days following oocyte retrieval (in fresh cycles) or during programmed estrogen/progesterone uterine replacement cycles (in frozen embryo transfers—FET cycles).

For patients who opt for surgical laparoscopy, excision or ablation of suspected endometriosis is performed, followed by management and advancement to IVF or FET. A recently published paper in the Journal of Assisted Reproduction and Genetics outlines the similar success of either laparoscopy or Depot Lupron (60 days) compared to cases of untreated positive BCL6. In this 7-year study, live birth rates went from around 10% in untreated patients to over 50% in treated patients.

For new users of ReceptivaDx, we are happy to provide references to centers with an established track record of treatment or a conversation with the authors of the study.

How Do I Interpret Different H-Score Results?

View here for a short review of cutoff values and interpretation

Who Is a Candidate for ReceptivaDx Testing?

Candidates include all women with unexplained infertility who:

Have failed one or more IVF cycles
Have limited fertility coverage
Have limited embryo reserves
Have experienced recurrent pregnancy loss

How Is the Test Performed?

The ReceptivaDx test is performed on an endometrial biopsy sample and sent to one of our accredited pathology labs. Results are faxed back to the sending IFV center in 7-10 days.

What Is the Sample Stability?

Samples are stable at room temperature during the entire shipping process and can be collected any day of the week. Biopsy timing information is provided below. Our ReceptivaDx collection kit comes complete with everything necessary to properly collect and submit a sample.

Is the Biopsy Date Dependent on the Patient’s Menstrual Cycle?

Yes. For a natural cycle, the biopsy should occur 7-10 days after ovulation. For a mock cycle, the biopsy should occur 5-10 days after the start of progesterone.

Samples are sent overnight to one of our testing facilities and results are typically available within 3-4 business days.

How Much Does the Test Cost?

The ReceptivaDx test (BCL6 only) costs $690. This includes overnight shipping costs via FedEx to our nearest licensed testing center. Additional markers can be added. CD138, a marker that identifies endometritis, can be ordered for an additional $145. Beta3 Integrin, a test for uterine receptivity, can be ordered for an additional $250.

Payment is required via credit card at the time of sample submission. Patients may call our offices to make the payment in advance if preferred. Cicero Diagnostics provides a receipt that can be used for reimbursement from insurance or healthcare spending accounts. To receive this detailed receipt, please provide an email address on the test request form.

International customers are responsible for the cost of shipping to our testing centers in the US.

What Are the Success Rates for Centers That Have Used ReceptivaDX?

Cicero is in the process of collecting success rates from multiple centers that have been using this test for at least one year. Initial results from many of our centers show success rates mimicking or exceeding the results recently published in a 7-year prospective study.

A high percentage of failed IVF patients moved from a 10% success rate with untreated endometriosis to over a 50% live birth rate after treatment. Some centers exceed a 70% pregnancy success rate. The aggregate statistics will be available mid–2019. Please contact us for more information.

Is There a Difference Between the ERA Test and ReceptivaDx?

While both tests are taken from an endometrial biopsy, the tests differ completely in purpose. The ERA (Endometrial Receptivity Analysis) is a test that evaluates the expression of genes in an attempt to define the optimal embryo transfer window.

The ReceptivaDx test does not evaluate transfer timing. ReceptivaDx detects the inflammation on the uterine lining that is most often associated with endometriosis. Uterine inflammation is a major cause of unexplained infertility, failed IVF, and recurrent pregnancy loss, even in cases where embryos have been tested and transfer timing has been optimized.

Who is Cicero Diagnostics?

Cicero Diagnostics, Inc. is a diagnostics company dedicated to the advancement of women’s healthcare. Cicero Diagnostics has exclusive rights to BCL6 analysis on endometrial tissue. Our company maintains relationships with key academic research centers.

We are dedicated to developing new testing modalities for endometriosis and unexplained infertility. Cicero Diagnostics maintains two laboratory locations in the US. Both of these testing sites are fully licensed and operate under CLIA-established guidelines for the best laboratory practices. Cicero Diagnostics is the only licensed provider in the US for the detection of BCL6 as a marker in endometrial biopsy samples.

Please feel free to contact us at 800-795-5385 for further information. International clients can email us at [email protected]om or call us at 1-714-951-9245.

Information for Physicians

Information for Healthcare Professionals

Frequently Asked Questions

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